FDA Inspection
Teena Bio Labs Private LtdTeena Bio Labs Private Ltd – FDA Inspection, Feb 9, 2018
Record Details
This FDA Inspection record concerns Teena Bio Labs Private Ltd, with an inspection on February 9, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · fa4c87d9-4282-4418-80ed-2833fa57f260
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1040338
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
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Other FDA inspections of Teena Bio Labs Private Ltd
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 5, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 16, 2017 | Not classified | Office of Inspections and Investigations |
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